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Regeneron gets FDA emergency license for COVID-19 antibody therapy

Image Source: casirivimab and imdevimab fact sheets by Regeneron Pharmaceuticals

Marilyn Marchione

U.S. health officials allow emergency use of secondary antibody drugs on Saturday to help the immune system fight COVID-19, an experimental drug given to President Donald Trump when he got sick last month. I agreed.

The Food and Drug Administration has regeneron Pharmaceuticals Inc. to prevent hospitalization and exacerbation of illness in patients with mild to moderate symptoms. Approved the use of the drug.

The drug is given as a one-time treatment via IV. The FDA has approved use for adults and children aged 12 years and older who weigh at least 88 pounds (40 kilograms) and are at high risk of serious illness due to COVID-19 due to age and other specific medical conditions. ..

Emergency permits allow you to start using the drug while the study continues to establish safety and efficacy. Early results suggest that the drug may reduce COVID-19-related hospitalizations and visits to emergency rooms in patients at high risk of disease progression, the FDA said.

Regeneron said the initial dose will be available to approximately 300,000 patients through a federal allocation program. Those patients are not charged for the drug, but may have to pay part of the cost of giving IV.

The initial supply could be significantly higher due to demand, as the United States has skyrocketed beyond the reported 12 million cases.

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Antibodies are proteins that help the body target and eliminate viruses, but it can take several weeks after an infection occurs before the best antibodies are formed. The drug is a concentrated version of what has proven to be the best way to do this in laboratory and animal experiments, and in theory it helps the body start fighting the virus immediately.

Regeneron drugs are a combination of two antibodies, kacilibimab and imdebimab, which increase the likelihood of proven efficacy. Earlier this month, the FDA granted an emergency permit for a single-antibody drug from Eli Lilly, which is still under study.

There is no way to know if a regeneron drug has helped Trump recover. He received many treatments and most COVID-19 patients recovered spontaneously.

FDA regulators have used emergency authority to approve Regeneron drugs to expedite the availability of laboratory drugs and other medical products in the event of a public health crisis.

The FDA usually requires “substantial evidence” to show that a drug is safe and effective, usually through the study of one or more large, tightly controlled patients. However, during public health emergencies, authorities can lower those standards and only demand that the potential benefits of experimental treatment outweigh the risks.

Emergency permits act like temporary approvals during the COVID-19 pandemic. To obtain full approval, Regeneron must submit additional studies to fully define the safety and benefits of the drug for the patient.

The White House wins Trump’s efforts to “provide cutting-edge treatments with very promising results to protect the health and safety of the most vulnerable Americans,” according to a statement by spokesman Michael Birds. Threw a decision as.

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AP Health Writer Matthew Perrone contributed to this report.

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The Associated Press’s Department of Health Sciences is supported by the Department of Science Education at the Howard Hughes Medical Institute. AP is solely responsible for all content.

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Source: Associated Press

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